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1110 NORTH SARAH DEWITT DRIVE

GONZALES, TX 78629

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0168

Based on record review of documentation and facility staff interviews, the facility failed to ensure the use of restraint was in accordance with an order of a physician or other licensed independent practitioner (LIP) who was responsible for the care of the patient as specified under §482.12(c) and authorized to order restraint or seclusion by hospital policy in accordance with State law for 1 of 5 Patient's reviewed (Patient #17) with the implementation of a restraint without an order for restraint.

Specifically, on 8/2/21 and 8/3/21, Patient #17 was restrained without a physician or LIP order.

Findings included:

Review of the facility's restraint log for 2021 revealed patient #17 was restrained on 8/2/21.

Review of Patient #17's medical records revealed documentation of restraints on 8/2/21 at 06:13 from Respiratory Therapy (RT).

On 8/3/21 at 00:10 the nursing notes documented patient pulling at Endotracheal (ET) tube, restless.

On 8/3/21 at 11:20 Nursing notes documented Patient #17 was extubated per RT and placed on oxygen at 2 Liters via nasal cannula. "Restraints [Discontinued] (DC'd.)".

Further review of Patient #17's medical record revealed there was not a physician order or LIP that authorized and ordered the use of restraint for Patient #17 in accordance with the facility's policy.

Review of the facility's Policy Titled Restraint and Seclusion Policy effective 9/3/2019 indicated under the area of Procedure: 1. Obtain a physician order specifying the reason for restraint. Restraints will only be used upon a written physician order.

In an interview on 9/1/21 at with the Director of Health Information confirmed that Patient #17's medical record did not include a Physician or LIP order for the implementation of restraint that was documented in Patient #17's records for 8/2/21 and 8/3/21.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0171

Based on record review and interview, the facility failed to ensure that each order for restraint used for the management of violent or self-destructive behavior was ordered with the following time limits: (A) 4 hours for adults 18 years of age or older in accordance with the facility's policy for 3 of 3 Adult Patients reviewed (Patient #14, #15 and #16) with orders for restraint for the management of behavior.

Specifically, Patient's #14, #15 and #16 Restraint Orders revealed the Physician's Orders (PO) did not document a 4-hour time limit for restraints and the facility was using a standard PO Restraint Order Form (Attachment B) that indicated implement restraint for; "5. Until behavior resolves-maximum 24 hour."

This deficient practice affected Patient #14, #15 and #16's rights.

Findings included:

Review of the facility's Policy Titled Restraint and Seclusion Policy effective 9/3/2019 revealed for Violent and Self-Destructive Restraint and/or Seclusion: The initial and all subsequent restraint orders shall expire in:
4 hours for adults 18 years of age or older,
2 hours for children and adolescents 9-17 years of age, and
1 hour for children 8 years of age or younger.
Restraints may be reordered according to the time limits for the maximum of 24 consecutive hours.

The policy included a form titled "Attachment B" for "Physician's Orders, Restraint Orders." The Attachment B Form Physician orders included Implement restraint, 5. Until behavior resolves-maximum 24 hour. The PO for Restraint Order did not specify a time limit or expiration in accordance with the facility policy of:
4 hours for adults 18 years of age or older,
2 hours for children and adolescents 9-17 years of age, and
1 hour for children 8 years of age or younger.

Review of Patient #14's records revealed the following:
A.) On 2/23/21 at 22:00 a PO for Restraint Orders (Attachment B) indicated Implement restraint for: "Hallucination" was checked and Implement restraint for 5. Until behavior resolves-maximum 24 hour. Review of the Restraint monitoring record documented patient was combative, disoriented/delusional and resistant to treatment.

B.) On 4/7/21 there was an Attachment B for a PO Restraint Order that was undated and untimed that indicated implement restraint for: "Confusion/Disorientation/Combativeness" was checked and Implement restraint for 5. Until behavior resolves-maximum 24 hour.

Review of Patient # 15 records revealed on 5/15/21 at 23:25 an Attachment B for PO for Restraint Order that indicated implement restraint for "Combativeness" circled. Implement restraint for 5. Until behavior resolves-maximum 24 hour.

Review of Patient #16 records revealed an electronic order dated 5/27/21 at 15:21 that indicated "Restraints (soft) per protocol." There were no other details or time limits.

Interview on 09/02/21 at 11:20 AM with the Chief Nursing Officer (CNO) stated that Restraint Orders were limited to 4 hours for an adult. The CNO confirmed the facility's form titled "Attachment B" used for PO Restraint Orders did not include a time limit and further confirmed the Form indicated "5. Until behavior resolves-maximum 24 hour." The CNO stated that form was an attachment from the Restraint and Seclusion policy and would need to be revised.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0174

Based on record review and interview, the facility failed to ensure restraints were discontinued at the earliest possible time according to the physician orders (PO) and facility policy for 4 of 4 Patient's reviewed (Patient #14, #15, #16 and #18) with continued restraints after the patients behavior(s) had resolved.

Specifically, Patient #14, #15 #16 and #18's PO indicated to implement restraint until behavior resolves-maximum 24 hour. Patient #14, #15, #16 and #18 remained in restraints when documentation specified Patients' were asleep and/or calm.

Findings included:

1.) Patient #14
Review of Patient #14's records revealed the following:
A.) On 2/23/21 at 22:00 a PO for Restraint Orders (Attachment B) indicated Implement restraint for: "Hallucination. Type of restraint: Soft wrist/ankle" checked. Implement restraint for "5. Until behavior resolves-maximum 24 hour."

Review of Patient #14's Restraint monitoring record for 2/23/21 through 2/24/21 revealed the following documentation:
At 22:00 documentation revealed patient was combative, disoriented/delusional and resistant to treatment.
22:15 (15 minutes later) documentation revealed patient was "Calm and Asleep." The restraints continued.
22:30 calm and asleep; and restraints continued.
22:45 calm and asleep; and restraints continued.
23:00 calm and asleep; and restraints continued.
23:15 calm and asleep; and restraints continued.
23:30 calm, and restraints continue.
23:45 calm and asleep; and restraints continued.
00:00 (2/24/21) calm and asleep; and restraints continued.
00:15 calm, and restraints continued.
00:30 calm, and asleep and restraints continued.
00:45 calm and asleep; and restraints continued.
01:00 calm, and restraints continued.
01:15 calm, and restraints continued.
01:30 calm, and restraints continued.
0145 calm and asleep. Restraints Discontinued (DC'd).

B.) On 4/7/21 there was an Attachment B for a PO Restraint Order that was undated and untimed that indicated Implement restraint for: "Confusion/Disorientation/Combativeness" was checked. Type of restraint: Soft wrist/ankle. Implement restraint for "5. Until behavior resolves-maximum 24 hour."

Review of Patient #14's Restraint monitoring record for 4/7/21 revealed the following documentation:
Page 1 Time Initiated at 02:40.
02:45 (5 minutes later) documentation revealed patient was "calm and asleep." The restraints continued.
03:00 calm and asleep; and restraints continued.
03:15 calm, and restraints continued.
03:30 Restless, and restraints continued.
03:45 Restless, and restraints continued.
04:00 Restless, and restraints continued.
04:15 Restless, and restraints continued.
04:30 Restless, and restraints continued.
04:45 Asleep, and restraints continued.
05:00 Asleep, and restraints continued.
05:15 Asleep, and restraints continued.
05:30 Asleep, and restraints continued.
05:45 Calm, and restraints continued.
06:00 Asleep and Calm; and restraints continued.
06:15 Asleep and Calm. All restraints removed at this time.

2. ) Patient #15
Review of Patient # 15 records revealed on 5/15/21 at 23:25 an Attachment B for PO for Restraint Order that indicated implement restraint for "Combativeness" circled. Type of restraint: Soft wrist/ankle. Implement restraint for "5. Until behavior resolves-maximum 24 hour."

Review of Patient #15's Restraint Monitoring Record revealed Restraint Initiated 23:25 on 5/15/21.
At 23:25 Patient was noted to be Combative.
23:40 Patient Restless.
23:55 Patient Asleep. Restraints continued.
00:10 Patient Asleep. Restraints continued.
00:25 Patient Calm. No further documentation after 00:25.

3.) Patient #16
Review of Patient #16 records revealed an electronic order dated 5/27/21 at 15:21 that indicated "Restraints (soft) per protocol." There were no other details or time limits.

Review of Patient #16's Restraint Monitoring Record revealed restraints initiated at 15:15 on 5/27/21. Nurse's note indicated Patient #16 was "supine in bed is restrained do to occasional movement of arms in a manner wich could jepardize the security of tube placement. The restraints are soft wrist restraints."
At 15:15 documentation indicated patient was "Asleep." Restraints remained.
15:30 Asleep, and restraints continued.
15:45 Asleep, and restraints continued.
16:00 Asleep, and restraints continued.
16:15 Asleep, and restraints continued.
16:30 patient transferred out. No further documentation.

4.) Patient #18
Review of Patient #18 records revealed on 8/14/21 at 15:47 a PO for Restraint Orders (Attachment B) indicated Implement restraint for: Removing medical devices was checked. Type of restraint: Soft wrist/ankle" checked. Implement restraint for "5. Until behavior resolves-maximum 24 hour."

Review of Patient #18's Restraint Monitoring Record dated 8/14/21 revealed time initiated at 15:47.
Nurse's note: 15:47 Restraints placed at this time. 19:00 Report given to RN.
At 16:00 Patient Restless.
16:15, 16:30, 16:45, 17:00, 17:15 and 17:30 Patient documented as, Restless.
17:45 Patient Asleep, "Sedated."
18:00 Patient Asleep, "Sedated."
18:15 Patient Asleep, "Sedated."
18:30 Patient Asleep, "Sedated."
18:45 Patient Asleep, "Sedated."
Nurse's Note 19:00 Took over care. Patient on vent sedated. Restraints in place.
19:00 "Sedated."
19:15 "Sedated."
19:30 "Sedated."
19:45 "Sedated."
20:00 "Sedated."
20:15 "Sedated."
20:30 "Sedated."
20:45 "Sedated."
21:00 "Sedated."
21:15 "Sedated."
21:30 "Sedated."
21:45 "Sedated."
22:00 "Sedated."
22:15 "Sedated."
22:45 "Sedated."
23:00 "Sedated."
23:15 "Sedated."
23:30 "Sedated."
23:45 "Sedated."
00:00 (8/15/21) "Sedated."
00:15 "Sedated."
00:30 "Sedated."
00:45 "Sedated."
01:00 "Sedated."
01:15 "Sedated."
01:30 "Sedated."
01:45 "Sedated."
02:00 "Sedated."
02:15 "Sedated."
02:30 "Sedated."
02:45 "Sedated."
03:00 "Sedated."
03:15 "Sedated."
03:30 "Sedated."
03:45 "Sedated."
04:00 "Sedated."
04:15 "Sedated."
04:30 "Sedated."
04:45 "Sedated."
05:00 "Sedated."
05:15 "Sedated."
05:30 "Sedated."
05:45 "Sedated."
06:00 "Sedated."
06:15 "Sedated."
06:30 "Sedated."
06:45 "Sedated."
07:00 "Sedated."
07:15 "Sedated."
07:30 "Sedated."
07:45 "Sedated."
07:50 Nurses' Note: 07:50 "Restraints DC'd."

Interview on 09/02/21 at 11:20 AM with the Chief Nursing Officer (CNO) stated that patients were to be released from restraints "as soon as you can; once cooperative, then remove restraints." The CNO stated that each department manager was to monitor the restraint records and documentation to ensure the nurses did everything according to policy and procedures for restraints.

Review of the facility's Policy Titled Restraint and Seclusion Policy effective 9/3/2019 revealed the following, in part; the facility's goal was to minimize the frequency and duration of restraints. Restraints will only be used when it is necessary for patient care and to provide safety. The use of restraints is used only as long as necessary to help a patient regain control of his behavior.

Procedure included: Restraints will be reassessed at each interval when restraints are released and will be removed as soon as patient condition permits.

The policy included a form titled "Attachment B" for "Physician's Orders, Restraint Orders." The Attachment B Form Physician orders included Implement restraint, 5. Until behavior resolves-maximum 24 hour.

MEDICAL RECORD SERVICES

Tag No.: A0450

Based on record review and interview, the facility failed to ensure patient medical record entries were legible, complete, dated, timed, and authenticated by the person responsible for providing or evaluating the service provided, consistent with hospital policies and procedures for 12 of 14 surgical medical records reviewed (Patient #24, #25, #26, #27, #28, #29, #30, #31, #32, #33, #34 and #35).

Findings included:

Review of patient's closed surgical medical records revealed Patient #24, #25, #26, #27, #28, #29, #30, #31, #32, #33, #34 and #35 had illegible or incomplete entries by the person responsible for providing the service.

Patient #24's Post Anesthesia evaluation was not dated or timed by the person responsible for providing or evaluating the service provided. The pre-anesthesia evaluation was not completed to include the pre-procedure vital signs were blank.

Patient #25's Pre and Post Anesthesia evaluation was not dated, timed, or signed by the person responsible for providing or evaluating the service provided.

Review of Patient #26's pre and post anesthesia record was not dated or; signed, dated or timed by the anesthesia provider of service. The Pre-Anesthesia Evaluation was incomplete and did not include the following on the form: Patient's Pre-procedure vital signs, documentation of airway/teeth/head and neck, history and system assessment review for: respiratory, cardiovascular, hepato/gastrointestinal, neuro/musculoskeletal, renal/endocrine review to include the documentation of within normal limits (WNL) checked on the form.

Patient #27's pre and post anesthesia record dated 5/28/21 was not completed to include the pre-procedure vital signs were blank.

Patient #28's Pre-Anesthesia evaluation was incomplete with a strike through the proposed procedure, the date on the Anesthesia record was illegible.

Patient #29's pre and post anesthesia record dated 5/17/21 was not completed to include the pre-procedure vital signs were blank. The time of the post anesthesia evaluation was blank.

Patient #30's intraoperative Anesthesia record dated 1/12/21 revealed the documentation of the controlled substance medications administered to the patient Intraoperatively were illegible. The Anesthesia record was timed for extubation and transfer to PACU as one event both occurring at 10:45.

Patient #31's Pre-Anesthesia evaluation dated "2/2/20" (surgery procedure 2/3/2021) was not timed by the provider of service and was incorrectly dated.

Patient #33's pre and post anesthesia record dated 5/14/21 did not have the patient's vital signs, height, weight, previous surgical history and complications reviewed prior to surgery by the provider of service and was not timed. Current medications were blank, or none was not checked. System assessment review for: respiratory, cardiovascular, hepato/gastrointestinal, neuro/musculoskeletal, renal/endocrine was blank, or to include the documentation of within normal limits (WNL) checked on the form was blank.

Review of Patient #34's pre-anesthesia evaluation record with an illegible date that was re-written over without proper error procedure was not timed by the provider of service. The Preoperative Evaluation section and Physical Exam section to include heart, lungs, and other were blank.

Patient #35's Pre-Anesthesia evaluation was not timed by the person providing or evaluating the service provided.

Interview on 9/1/2021 at 10:07 AM with the Certified Registered Nurse Anesthetist conducted in facility conference room confirmed the above findings for Patient's #24, #25, #26, #27, #28, #29, #30, #31, #32, #33, #34 and #35).

Interview on 9/1/21 at 11:05 with the Director of Health Information Management (HIM) confirmed the above findings for Patient's #24, #25, #26, #27, #28, #29, #30, #31, #32, #33, #34 and #35 medical records. The Director of HIM stated there had been a recent education project completed with providers to ensure medical records were legible, completed, dated, timed, and authenticated by the provider.

Review of the facility's Pre and Post Anesthesia Evaluation Policy last revised 4/11/2018 revealed the elements of a preanesthesia evaluation shall be performed within 48 hours prior to any surgery and include the following elements of the preanesthesia evaluation:
-Review of the medical history, including anesthesia, drug and allergy history.
-Interview and examination of the patient.
Elements also included the patient condition prior to anesthesia.

Further review revealed the elements of an adequate post anesthesia evaluation should be clearly documented and conform to current standards of anesthesia care, including:
-Respiratory function, including respiratory rate, airway patency and oxygen saturation.
-Cardiovascular function, including pulse rate and blood pressure.
-Mental status
-Temperature
-Pain
-Nausea and vomiting
-Postoperative hydration
-Other monitoring as appropriate.

Review of the facility's Intraoperative Documentation Requirements for Anesthesia policy effective 10/19/2011 revealed the person providing anesthesia to a patient will document the following during anesthesia which included: 3. Name, dose, route and time of all drugs and anesthetizing agents.

PHARMACY DRUG RECORDS

Tag No.: A0494

Based on observation, review of documents, and interview, the facility failed to ensure that processes and procedures were implemented to ensure the accurate record and accountability of expired scheduled drugs/controlled medications were accounted for in order to minimize the risk of drug diversion.

Findings included:

Observations conducted in the Pharmacy on 8/30/21 at 3:30 PM with the Pharmacy Director present revealed the following:

The pharmacy vault used for scheduled controlled substances contained expired medications pending disposal. There was a plastic bag of 10 medication vials labeled Midazolam (Versed) (Schedule IV Controlled substance) 2mg/2ml (1mg/ml) 2ml Single-Dose Vial that were expired.

There was a plastic bag observed with a patient's prescription bottle labeled "Tramadol 50mg" (Schedule IV Controlled Substance), dated 5/21/20 and a paper attached to it titled "Receipt for Patients Personal Medication."

There was a plastic bag of 3 medication vials labeled Midazolam 10mg/2ml (5mg/ml) 2mg single dose vial that were expired.

During an interview on 8/30/21 at 3:35 PM with the Pharmacy Director stated that the loose bags of medications observed in the pharmacy vault were medications to be disposed of and were pending pick up from the contractor. The Pharmacy Director further explained that he kept a log to ensure that these observed scheduled IV medications were accounted for while in process for disposal. The Pharmacist was asked about the bottle labeled Tramadol 50mg and he stated this was a home medication that was probably lost or left at the hospital after a patient was discharged or expired. He explained that nursing staff were to deliver lost or unused medications to the pharmacy for disposal. The Pharmacy Director stated that medications scheduled for disposal occurred "at least monthly;" but that it could be quarterly; as well. The Pharmacy Director further confirmed the Patient's prescription bottle labeled Tramadol 50mg was from 2020 and stated he was not sure why the Tramadol bottle was in the vault and had not been disposed of.

Further observations in the pharmacy on 8/30/21 at 5:00 PM, survey team members met with the Pharmacy Director to further observe the expired medications for disposal in the pharmacy vault and conduct a joint reconciliation utilizing the facility's log/documentation. The Pharmacy Director then provided the surveyors a log of medications scheduled for disposal titled; "CSM Expired Bin Inventory Summary."

Review of the CSM Expired Bin Inventory Summary dated 8/30/21 at 4:48 PM documented medications in the disposal bin pending disposal. A reconciliation of the observed medications for disposal in the pharmacy vault was conducted in comparison to the CMS Expired Bin Inventory Summary report dated 8/30/21 at 4:48 PM which revealed the 10 vials of Midazolam 2mg/2ml observed were not listed on the Expired Bin Inventory Summary. The patient's bottle of Tramadol 50mg was not listed on the Expired Bin Inventory Summary sheet. The 3 vials of Midazolam 10mg/2ml (5mg/ml) 2ml single dose were documented on the Expired Bin Inventory as Midazolam 5mg/1ml, 2 ML inj [injection]; instead of 10mg/2ml in accordance with the vial's label.

Further interview on 8/30/21 at 5:25 PM with the Pharmacy Director stated the Patient's Tramadol medication that was not listed on the CSM Expired Bin Inventory Summary may have been listed on an archived document kept outside of the hospital. The Pharmacy Director confirmed the 3 vials of Midazolam labeled 10mg/2ml did not correspond with the list in volumes and strengths on the Expired Bin Inventory summary and stated that the overall volumes were corresponding with the strengths; but he did understand that this was confusing. The Pharmacy Director confirmed the 10 vials of Midazolam 2mg/2ml that were found in the bin were not in the inventory/log kept by pharmacy and stated someone forgot to add them into the expired log.

Review of the facility's Pharmacy Inventory Policy dated 07/02/08 revealed the inventory of the hospital shall be maintained in the Pharmacy. Expired controlled substances will also be inventoried.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on observations, interviews with facility staff, and record review, the facility failed to maintain a clean, sanitary, and safe physical environment in order to prevent and control the transmission of infections within the hospital.

Specifically, the facility failed to:
1.) ensure the cleanliness and sanitation of the physical environment and,

2.) maintain humidity in 3 of 3 operating rooms in accordance with the Association of perioperative Registered Nurses (AORN); the recommended humidity range in an operating room is 20% to 60%. Excessive humidity is conducive to microbial growth and placed the patients undergoing procedures in these operating rooms at risk for infections affecting the quality of care provided.

Findings included:

1.) Observations conducted on 8/31/21 at 12:47 PM of the Emergency Department (ED) with the Emergency Department Manager present revealed the following:

A.) The intravenous medication mixing area was not clean with soilage observed. The sink faucet and handles had built up debris. The sink area countertop had deep dark rust color stains and the laminate countertop was peeling/damaged; exposing the wood surface.

B.) One of the ED crash carts had two Endotracheal tubes (ETT) expired in the airway section.

C.) A second ED crash cart drawers were dusty, and a dead insect was found inside one of the medication drawers of the cart. The bottom of the crash cart was soiled with substance. There were sealed instruments and sealed bags of IV fluids plus miscellaneous items were found in this soiled space. The supplies had a heavy dust cover.

In an Interview with the ED manager on 8/31/21 at 12:50 PM during observations confirmed the above findings and indicated the facility was old. The ED manager confirmed the stains and soilage observed. The ED manager stated that the crash carts were checked every shift and was not sure why the expired ETT were not found. The ED manager further stated regarding the items in the second crash card; that no one used those items and that they fall sometimes into that space. The ED manager indicated that he would clean the crash carts immediately and that one of his process improvement plans was to organize and standardize the crash carts.

2.) Observations on 9/1/21 at 11:44 AM of the Obstetrics (OB) area revealed the following: The crash cart was dirty with stains and heavy dust. The bottom space of the cart was noted to be heavily soiled with unknown substances where medical equipment was stored; which included two multi-lumen central line kits stored in the crash cart. The top of the cart had dust and substance debris. A reusable Blood pressure cuff bag was found to have dark rust color stains and brown substances on its label.

Interview on 9/1/21 at 11:45 AM with Staff #19 confirmed the above findings and stated they would clean the crash cart and soiled items.

3.) Observations on 9/1/21 at 12:11 PM of the Medical-Surgical (Med Surg) area revealed the following:

A.) A medicine cart was found in poor functional condition and dirty. Stains appeared to be mold, mildew and rust like; but could not be verify at the time. The cart was being used by nursing staff to deliver scheduled medications to patients. The medicine cubbies (small drawers) were dirty and stained with black and brown substances. The handles of the cart were also dirty with dark color stains.

B.) A closet contained empty and full oxygen tanks placed side by side. The empty oxygen tanks were dirty equipment stored in a clean space.

Interview on 9/1/21 at 12:15 PM with Staff #21 was not able to indicate when the medication cart observed on the med surg floor had last been cleaned and did not know who was responsible for cleaning this medication cart. Further interview revealed Staff #21 was not able to indicate if the dirty oxygen tanks were cleaned prior to be placed in a clean space with the full oxygen tanks.

Review of the facility's Policy titled Infection Prevention and Control Program last updated 2/11/21 revealed the Infection Preventionist and the Infection Control Program (IPC) Committee shall be responsible for identifying, investigating, reporting, preventing and controlling infections and communicable diseases through the following activities: a. Maintenance of a sanitary facility environment.

4.) Observations conducted on 8/31/21 at 11:03 AM of Operating Room (OR) #3 revealed the Fluke meter used by the OR Director indicated it was 64.7 % relative humidity.

Observations conducted on 8/31/21 at 11:25 AM of Operating Room #2 revealed the Fluke meter used by the OR Director indicated it was 64.8% relative humidity.

In an interview with the OR Director on 8/31/21 at 11:30 AM stated the facility continually "battles temperature and humidity" issues. The OR Director stated she would notify maintenance and do a work order if the humidity was noted to be over 65% and condensation was noted.

Review of the Temperature, Humidity and Positive Pressure log for OR #2 revealed for 8/31/21 the Humidity was documented at 62% at 06:30 AM. Further review of the log form for August 2021 indicated Humidity Target was less than 60% and for humidity greater than 65%, alert alarm-notify plant ops and supervisor. The Humidity was noted to be over 60% for 18 of 21 days recorded; and OR was down for repair for 6 days.

Review of the Temperature, Humidity and Positive Pressure log for OR #3 revealed for 8/31/21 the Humidity was documented at 66% at 06:30 AM. Further review of the log form for August 2021 revealed the Humidity was noted to be over 60% for 23 of 26 days recorded; and OR was down for repair for 3 days.

Review of the Temperature, Humidity and Positive Pressure log for OR #1 revealed for 8/31/21 the Humidity was documented at 62.3% at 06:26 AM. Further review of the log form for August 2021 revealed the Humidity was noted to be over 60% for 21 of 28 days recorded.

Review of the Governing Board of the facility from January 2021 thru July 2021 revealed but was not limited to the following information regarding the operating room (OR) temperature/humidity issue:
January 5, 2021: The Director of Risk Management presented the following report: "We are waiting on bids to correct the OR temperature/humidity issue."
March 2nd, 2021: Chief Executive Officer (CEO) Report presented by the CEO: "We are still looking at the humidity levels in ER."
April 6th, 2021: CEO report as presented by the CEO: "Humidity levels continue to be an issue in OR, however, there have been parameters set as to how low and how high temps are allowed to go."

Review of the Medical Staff Meeting Minutes of 05/18/2021 revealed but was not limited to the following: "The Infection Control Committee met on May 13, 2021. Daily monitoring of temperature and humidity in critical areas (central processing, OR1, OR2 and OR3) demonstrated 87 incidents with temperature and humidity. The current HVAC system is a partial cause, but it was noted that temperature sticks were not connecting via WiFi on the weekends. An electronic monitoring system has been budgeted.

In an interview on 9/2/21 at 11:35 AM with the Director of Plant Operations stated he adjusts the units temperatures as much as he is able to control when he gets the alerts that the temperature or humidity are out of range in the surgical area where central processing and the Operating Rooms are located. The Director of Plant Ops stated that he is trying to get approval to order a new HVAC unit that has been in the works and that he has been in contact with an engineer.

Review of the facility's policy titled Humidity, Temperature, Pressure, and Air Exchanges Monitoring and Response for Critical Areas effective 4/6/21 revealed the maximum humidity for Sterile Processing and Sterile Storage was 60%. The Operating Room Humidity was to be between 30% and 60%.

Review of the Safety Committee Meeting Minutes dated May 24th, 2021 revealed there were no environmental rounds completed for the month of April.

Review of the Safety Committee Meeting Minutes dated June 24th, 2021 revealed there were no environmental rounds completed for the month of May.

Review of the Safety Committee Meeting Minutes dated July 21st, 2021 revealed there were no environmental rounds completed for the month of June. The Safety Manager was working with the Plant Operations Director and Infection Control manager on creating a collaborative team to perform environmental rounds to start in August.

PRE-ANESTHESIA EVALUATION

Tag No.: A1003

Based on a review of clinical records and interview, the pre-anesthesia assessment evaluations completed by Certified Registered Nurse Anesthetist for 9 of 14 Patient's (Patient #26, #27, #28, #29, #30, #31, #32, #33, and #34) surgical records reviewed were not thoroughly completed and/or timed in accordance with the facility's policy and general anesthesia standard of care.

Findings included:

Review of Patient #26's pre and post anesthesia record was not dated or; signed, dated or timed by the anesthesia provider of service. The Pre-Anesthesia Evaluation was incomplete and did not include the following on the form: Patient's Pre-procedure vital signs, documentation of airway/teeth/head and neck, history and system assessment review for: respiratory, cardiovascular, hepato/gastrointestinal, neuro/musculoskeletal, renal/endocrine review to include the documentation of within normal limits (WNL) checked on the form.

Review of Patient #27's pre and post anesthesia record dated 5/28/21 was not completed to include the pre-procedure vital signs were blank.

Review of Patient #28's pre and post anesthesia record dated 5/28/21 documented "See Pre-OP from 5/21/21" (7 days prior). The preanesthesia evaluation did not have the patient's vital signs, height, weight, current medications, allergies, previous surgical history and complications reviewed prior to surgery by the provider of service.

Patient #29's pre and post anesthesia record dated 5/17/21 was not completed to include the pre-procedure vital signs were blank.

Review of Patient #30's pre-anesthesia evaluation dated 1/12/21 revealed the Physical Exam section to include heart, lungs, and other were blank.

Review of Patient #31's pre-anesthesia evaluation dated "2/2/20" (surgery procedure 2/3/2021) was not timed by the provider of service and was incorrectly dated. The Preoperative Evaluation section and Physical Exam section to include heart, lungs, and other were blank.

Review of Patient #32's pre and post anesthesia record dated 5/24/21 was not completed to include the pre-procedure vital signs were blank.

Review of Patient #33's pre and post anesthesia record dated 5/14/21 did not have the patient's vital signs, height, weight, previous surgical history and complications reviewed prior to surgery by the provider of service and was not timed. Current medications were blank, or none was not checked. System assessment review for: respiratory, cardiovascular, hepato/gastrointestinal, neuro/musculoskeletal, renal/endocrine was blank, or to include the documentation of within normal limits (WNL) checked on the form was blank.

Review of Patient #34's pre-anesthesia evaluation record with an illegible date that was re-written over without proper error procedure was not timed by the provider of service. The Preoperative Evaluation section and Physical Exam section to include heart, lungs, and other were blank.

In an interview with Certified Registered Nurse Anesthetist on 9/1/21 at 10:07 AM in the facility's conference room confirmed the above findings for Patient's #26, #28, #30, #31, #33, and #34; upon review in that the Pre-Anesthesia evaluations were incomplete in accordance with the policy and the form used. She further stated, "I need to fill it out. It's my error."

Review of the facility's Pre and Post Anesthesia Evaluation Policy last revised 4/11/2018 revealed the elements of a preanesthesia evaluation shall be performed within 48 hours prior to any surgery and include the following elements of the preanesthesia evaluation:
-Review of the medical history, including anesthesia, drug and allergy history.
-Interview and examination of the patient.
Elements also included the patient condition prior to anesthesia.

INTRAOPERATIVE ANESTHESIA RECORD

Tag No.: A1004

Based on review of clinical records and interview, the intraoperative anesthesia records for 2 of 14 Patient's surgical records reviewed (Patient #28 and #30) were not accurately completed by the Certified Registered Nurse Anesthetists (CRNA) at the time of administration of drugs and anesthesia agents and; in accordance with the facility's policy.

Findings included:

Review of Patient #28's surgical record dated 5/25/21 revealed the intraoperative Anesthesia record with an illegible date documented by Certified Registered Nurse Anesthetists (CRNA), indicated Toradol was given Intraoperatively but crossed out indicating "error, not given" without initials or date.

Review of Patient #30's intraoperative Anesthesia record dated 1/12/21 revealed the documentation of the controlled substance medications administered to the patient Intraoperatively were illegible. Further review revealed a comment documented and initialed by CRNA, dated 1/15/21 that "50 mcg added to original chart." There was no indication of what medication of "50 mcg" was added during the surgical procedure. Surgical procedure was performed 1/12/21.

Interview on 9/1/21 at 10:07 with the CRNA confirmed her handwriting was illegible upon review of Patient #30's Anesthesia record and stated that the anesthesia record "form" was edited to include the "typed" anesthetizing agents to prevent her from having to handwrite them on the form. The CRNA further confirmed that Patient #28 and #30's Anesthesia records were edited post-operative anesthesia regarding the administration of anesthesia medication because the Pharmacy Director notified her of discrepancy errors found upon reconciliation of the Omnicell controlled substance reports. The CRNA confirmed that her intraoperative anesthesia administration should be documented at the time of administration stating, "I forgot" for Patient #30 and then "corrected it."

Review of the facility's Intraoperative Documentation Requirements for Anesthesia policy effective 10/19/2011 revealed the person providing anesthesia to a patient will document the following during anesthesia which included: 3. Name, dose, route and time of all drugs and anesthetizing agents.

Review of Departmental Performance Improvement Committee Minutes, dated February 8, 2021, revealed one anesthesia record that was retrospectively corrected.

Review of Departmental Performance Improvement Committee Meeting Minutes, dated March 8th 2021, revealed three anesthesia records that were retrospectively corrected.

Review of Departmental Performance Improvement Committee Minutes, dated June 14, 2021, revealed seven anesthesia records that were retrospectively corrected.

Review of the Medical Staff Meeting Minutes, dated 07/27/2021, revealed but was not limited to the following: Pharmacist's Report: There were also seven anesthesia records that required retrospective corrections.

POST-ANESTHESIA EVALUATION

Tag No.: A1005

Based on a review of clinical records and interview, the post-anesthesia assessment evaluations reviewed for 2 of 14 Patient's (Patient #26, and #35) were not completed in accordance with current standards of anesthesia care and the facility's policy to include a minimum of the assessment for: respiratory function, including rate, airway patency and oxygen saturation; pulse rate, blood pressure, mental status, temperature, pain, nausea and vomiting and postoperative hydration.

Findings included:

Review of Patient # 26's pre and post anesthesia record (undated) revealed the post-anesthesia evaluation assessment was blank, undated and unsigned by the anesthesia provider. The Post-Anesthesia Evaluation assessment included the airway of the patient, vital signs, physical status, oxygen status, provider signature, date, and time of assessment.

Review of Patient #35's pre and post anesthesia record dated 6/17/21 revealed the post-anesthesia evaluation assessment did not include vital signs, temperature and oxygen status. The post-anesthesia assessment was not timed by the provider of care.

An interview with the Certified Registered Nurse Anesthetist (CRNA) at 10:07am on Sept 1, 2021 in the facility's conference room confirmed the above findings for Patient #26 and #35. The CRNA stated that "I need to fill it out. It's my fault;" referring to the Pre and Post anesthesia record evaluations and report documentation.

Review of the facility's Pre and Post Anesthesia Evaluation Policy last revised 4/11/2018 revealed the elements of an adequate post anesthesia evaluation should be clearly documented and conform to current standards of anesthesia care, including:
-Respiratory function, including respiratory rate, airway patency and oxygen saturation.
-Cardiovascular function, including pulse rate and blood pressure.
-Mental status
-Temperature
-Pain
-Nausea and vomiting
-Postoperative hydration
-Other monitoring as appropriate.